Status:
TERMINATED
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) ...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
- Detectable HBV DNA (as measured by PCR)
- HBeAg positive and negative patients
- Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
- Elevated serum alanine aminotransferase (ALT)
- Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation
Exclusion
- Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
- Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
- Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
- Planned other than Pegasys antiviral treatment during Pegasys therapy
- Chronic liver disease other than chronic hepatitis B
- Pregnant or breast-feeding women
- Inadequate hematologic function
- Autoimmunology disorders
- Co-infection with chronic hepatitis C or HIV
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01794234
Start Date
August 1 2012
End Date
September 1 2013
Last Update
November 2 2016
Active Locations (9)
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1
Bytom, Poland, 41-902
2
Dębica, Poland, 39-200
3
Gdansk, Poland, 80-214
4
Krakow, Poland, 31-202